利伐沙班口崩片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
对照品批号430060-202202对照品来源中检所对照品使用方法直接使用
对照品含量(%)99.6对照品水分(%)0对照品稀释倍数1000
标示量(mg)15供试品稀释倍数1系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
1 14.994773694775344768484764724766524769750.10
2 15.034783714787864785780.07
单位质量响应值RSD%判断
31819.5531841.520.05数据可信
供试品溶液-JPS7837批-pH1.2
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min142763-427638.0298.586.618.038.586.60
247039-470398.8318.83
344586-445868.3718.37
451160-511609.6059.60
544495-444958.3548.35
644075-440758.2758.27
10min179988-7998815.01715.492.0515.0315.512.05
282668-8266815.52015.54
383628-8362815.70115.71
484876-8487615.93515.95
582513-8251315.49115.51
681502-8150215.30215.32
15min1106251-10625119.94820.491.6019.9920.531.60
2109782-10978220.61120.65
3110998-11099820.83920.88
4110603-11060320.76520.81
5108953-10895320.45520.50
6108307-10830720.33420.37
20min1126422-12642223.73524.281.4523.8124.361.45
2131042-13104224.60224.68
3131352-13135224.66124.74
4130110-13011024.42724.50
5128684-12868424.16024.23
6128349-12834924.09724.17
30min1155052-15505229.11029.971.7929.2230.081.79
2161878-16187830.39230.51
3161812-16181230.37930.50
4158803-15880329.81429.93
5158010-15801029.66529.78
6162150-16215030.44330.56
45min1187341-18734135.17235.922.5735.3336.082.57
2193646-19364636.35636.52
3200268-20026837.59937.77
4189654-18965435.60635.77
5189160-18916035.51435.68
6187845-18784535.26735.43
60min1209229-20922939.28239.861.3439.5040.091.34
2216347-21634740.61840.85
3215025-21502540.37040.60
4212376-21237639.87240.10
5210863-21086339.58839.81
6210116-21011639.44839.67
极限1247440-24744046.45546.951.1646.7447.241.16
2253852-25385247.65947.95
3252875-25287547.47647.77
4250732-25073247.07447.37
5248529-24852946.66046.95
6246953-24695346.36446.65
利伐沙班口崩片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
对照品批号430060-202202对照品来源中检所对照品使用方法直接使用
对照品含量(%)99.6对照品水分(%)0对照品稀释倍数1000
标示量(mg)15供试品稀释倍数1系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
1 14.994771564775714755964773914776064770640.18
2 15.034797944777574787760.31
单位质量响应值RSD%判断
31825.4831854.690.07数据可信
供试品溶液-JPS7837批-pH4.5
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1163962-16396230.77431.183.2230.7731.183.22
2173385-17338532.54232.54
3167186-16718631.37931.38
4166425-16642531.23631.24
5157240-15724029.51229.51
6168427-16842731.61231.61
10min1214572-21457240.27340.942.8340.3241.002.83
2222741-22274141.80641.86
3225900-22590042.39942.45
4216846-21684640.69940.75
5208652-20865239.16139.21
6220213-22021341.33141.38
15min1239502-23950244.95245.302.0445.0745.422.04
2244080-24408045.81145.93
3247223-24722346.40146.52
4241185-24118545.26845.39
5232916-23291643.71643.83
6243322-24332245.66945.79
20min1254737-25473747.81148.001.6348.0048.191.64
2258007-25800748.42548.63
3260588-26058848.90949.11
4255021-25502147.86448.06
5248441-24844146.62946.82
6257517-25751748.33348.53
30min1270338-27033850.73951.251.8251.0151.531.82
2276605-27660551.91552.20
3280277-28027752.60552.89
4272162-27216251.08251.36
5265979-26597949.92150.19
6273041-27304151.24751.52
45min1284906-28490653.47353.561.1053.8353.921.10
2285501-28550153.58553.95
3289478-28947854.33254.70
4284660-28466053.42753.79
5280215-28021552.59352.94
6287431-28743153.94754.31
60min1291240-29124054.66254.790.6755.1155.240.68
2290562-29056254.53554.99
3294921-29492155.35355.81
4291690-29169054.74755.20
5289594-28959454.35354.79
6293396-29339655.06755.52
极限1294753-29475355.32255.550.4755.8656.090.49
2296134-29613455.58156.13
3297745-29774555.88356.44
4296491-29649155.64856.19
5293935-29393555.16855.69
6296700-29670055.68756.23
利伐沙班口崩片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
对照品批号430060-202202对照品来源中检所对照品使用方法直接使用
对照品含量(%)99.6对照品水分(%)0对照品稀释倍数1000
标示量(mg)15供试品稀释倍数1系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
1 14.994787454779504782024778514771294779750.13
2 15.034754834747804751320.11
单位质量响应值RSD%判断
31886.2631612.240.62数据可信
供试品溶液-JPS7837批-pH6.8
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min160193-6019311.33010.597.5411.3310.597.54
258113-5811310.93910.94
354316-5431610.22410.22
459001-5900111.10611.11
557210-5721010.76910.77
648606-486069.1499.15
10min199167-9916718.66618.602.5818.6818.612.58
299452-9945218.72018.74
397065-9706518.27018.29
4102614-10261419.31519.33
599424-9942418.71418.73
695071-9507117.89517.91
15min1125089-12508923.54523.722.0823.6023.772.08
2126777-12677723.86323.91
3124516-12451623.43723.48
4130404-13040424.54624.60
5126632-12663223.83623.88
6122733-12273323.10223.15
20min1145233-14523327.33727.471.5227.4327.551.52
2146574-14657427.58927.68
3144656-14465627.22827.31
4149828-14982828.20228.29
5145885-14588527.46027.55
6143321-14332126.97727.06
30min1172287-17228732.42932.661.6932.5632.791.70
2174629-17462932.87033.01
3174651-17465132.87433.01
4177752-17775233.45833.60
5172554-17255432.48032.61
6169073-16907331.82431.95
45min1200550-20055037.74938.031.5037.9438.221.50
2204629-20462938.51738.71
3202083-20208338.03838.22
4206116-20611638.79738.99
5201304-20130437.89138.08
6197627-19762737.19937.38
60min1221188-22118841.63441.831.3541.8942.081.36
2225042-22504242.35942.61
3222821-22282141.94142.19
4225906-22590642.52242.78
5220809-22080941.56341.81
6217761-21776140.98941.23
极限1250804-25080447.20846.931.0647.5347.251.06
2251817-25181747.39947.72
3248845-24884546.84047.16
4251738-25173847.38447.71
5247322-24732246.55346.87
6245306-24530646.17446.49
利伐沙班口崩片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
对照品批号430060-202202对照品来源中检所对照品使用方法直接使用
对照品含量(%)99.6对照品水分(%)0对照品稀释倍数1000
标示量(mg)15供试品稀释倍数1系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
1 14.994775634782034772114768574768524773370.12
2 15.034788074793414790740.08
单位质量响应值RSD%判断
31843.7031874.520.07数据可信
供试品溶液-JPS7837批-pH4.5(内含%SDS)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1406514-40651476.25275.373.0476.2575.373.04
2384944-38494472.20672.21
3407552-40755276.44776.45
4411255-41125577.14277.14
5387904-38790472.76172.76
6412767-41276777.42577.43
10min1487713-48771391.48390.102.3291.6190.232.32
2479325-47932589.91090.03
3484821-48482190.94191.07
4488906-48890691.70791.84
5458795-45879586.05986.18
6482459-48245990.49890.63
15min1513461-51346196.31394.842.0796.5995.122.07
2506397-50639794.98895.26
3506952-50695295.09295.37
4514495-51449596.50796.79
5485598-48559891.08691.35
6506897-50689795.08295.36
20min1522594-52259498.02697.142.1798.4797.582.17
2517332-51733297.03997.47
3526593-52659398.77699.21
4526304-52630498.72299.16
5496484-49648493.12893.54
6518068-51806897.17797.62
30min1534212-534212100.20599.022.14100.8199.612.14
2528587-52858799.15099.74
3530740-53074099.554100.16
4536935-536935100.716101.32
5505630-50563094.84495.42
6531120-53112099.625100.23
45min1539413-539413101.18199.782.28101.95100.542.28
2535485-535485100.444101.20
3535412-535412100.430101.20
4542283-542283101.719102.49
5508666-50866695.41396.14
6530488-53048899.507100.27
60min1540235-540235101.335100.241.32102.27101.161.33
2535059-535059100.364101.29
3534194-534194100.202101.14
4542671-542671101.792102.74
5522720-52272098.05098.94
6531367-53136799.672100.60
极限1541238-541238101.523100.012.23102.63101.112.23
2535622-535622100.470101.56
3535038-535038100.360101.46
4542143-542143101.693102.81
5509863-50986395.63896.69
6535234-535234100.397101.50
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